This invention relates generally to intravenous (I-V) catheter placement devices that reduce the likelihood of accidental needlestick injuries. In recent history, preventing the transmission of contagious diseases, particularly those brought about by the co-mingling of human body fluids, has been of great technological interest. One of the particular problems has been associated with the use and disposal of I-V catheter introducer needles by health care workers. There have been various devices developed for the destruction of the introducer needles or cannula used with I-V catheters. Additional devices have been developed for the capping or hooding of I-V catheter introducer needles, all of which attempt to minimize the likelihood of needlestick injuries to health care workers and others after the needles have been used. The accidental puncture or pricking of a finger, or any other part of the body, after the treatment of a patient with a contagious disease, particularly a deadly contagious disease, results in a high likelihood of transmission of blood borne pathogens and the associated disease.
It is thus an object of this invention to provide an I-V catheter placement system which minimizes the likelihood of accidental needlestick injuries.
It is a further object of this invention to provide such an I-V catheter placement device which, after utilization with a patient, captures, encapsulates, and isolates the used needle so as to render such needle harmless.
It is a further and more particular object of this invention to provide such an I-V catheter injection device that has two stages of needle isolation, which provides magnification of blood xe2x80x9cflash-backxe2x80x9d in the device, which provides blood flow restriction, and which is operable utilizing only one hand which remains always behind the tip of the needle during the operation of the device and its safety features.
It is a still further object of the invention to provide a simple device which is manufacturable in high volumes.
These as well as other objects are accomplished by an I-V catheter injection device having a hollow body or barrel, with a nose attached to one end of the body and closed at the opposite end. The nose is disposed to the interior of said hollow body through a passageway, integral to the nose.
One end of a hollow needle, which is embedded in a hollow and transparent needle hub, is controlled in the passageway within the nose by a shaft appendage of the needle hub, and is in contact with energy storage means such as a spring, placed into the passageway ahead of the needle hub shaft. The other end of the needle passes through the spring and the passageway, and protrudes through boot (which may be elastic or rigid) that is attached to the nose of the catheter injection system. Covering the exposed shaft of the needle, while leaving the point of the needle exposed, is a thin wall concentric sleeve, or catheter, which is free to slide completely along the distal end of the needle. The needle hub shaft, onto which the opposite, proximal end of the needle is attached, is fixed to a transparent needle hub. The needle hub has two symmetrical winged beams, which are cantilevered from the back of the needle hub in the direction of the needle hub shaft and project at an angle away from the needle hub shaft and needle hub.
The geometry of the distal end of each winged beam is defined with angled catches for fixing the needle hub, with the spring in contact with it, into retainer slots in the sidewall of the nose. On the adjacent side of each catch is a release contact point for operationally releasing the needle hub from retainer slots during retraction of the needle and needle hub into the body of the device during use of the device. In an assembled state, the needle hub is held by one of the catches on the winged beams in position in the nose against the spring and ready for use. The opposite catch floats in its nose slot, which is slightly longer than the first nose slot, until actuation of the retraction cycle.
Use of the I-V catheter placement device is accomplished by holding the device at the finger grips in one hand with the orientation message xe2x80x9cUSE THIS SIDE UP,xe2x80x9d inscribed on the body of the device, visible to the clinician and with the needle pointing away from the clinician. The injection site of the patient is held with the other hand, such that the second hand is behind the needle at all times and is thus shielded from possible accidental needlestick. The introducer needle, with the catheter, is then injected part way into the patient""s vein at the desired location, such that just the tip of the needle and catheter have been inserted. The clinician then receives visual verification of proper veinal placement of the needle and catheter by observing the appearance of blood xe2x80x9cflash-backxe2x80x9d in the inner cavity of the needle hub (which is magnified).
When proper entrance of the needle and the catheter tip into the patient""s vein is confirmed, two release tabs on the sides of the body of the device are simultaneously depressed and released, causing the needle tip to retract just inside the tip of the catheter. As the needle and needle hub retract, visible indication of such retraction is provided to the clinician, whereby the needle hub is stopped at a fixed reference line on the body labeled as xe2x80x9c1xe2x80x9d. In addition, audible indication of such retraction is provided by a xe2x80x9cclickingxe2x80x9d sound which is audible when the release tabs are depressed, and again when they are released. With the needlepoint effectively blunted inside the tip of the catheter, complete insertion of the catheter is then accomplished by the user without risk of the needle tip piercing the backside of the vein and thus xe2x80x9cblowing the vein.xe2x80x9d
Once the catheter is properly inserted into the patient""s vein, the two release tabs on the sides of the body are again simultaneously depressed and released. This action releases the remaining needle hub catch from its slot in the nose, and the needle hub with the needle attached thereto, is projected by stored energy in the spring (or other energy storage means) into and retained within the body of the device. Visible verification of such needle retraction is provided to the clinician by him or her observing that the needle hub is positioned at a second fixed reference line at the back of the body of the device labeled as xe2x80x9c2.xe2x80x9d In addition, audible indication of such retraction is provided by a xe2x80x9cclickingxe2x80x9d sound which is audible when the release tabs are depressed. As the needle tip passes the boot at the nose of the device, the hole in the boot through which the needle has passed closes, and blood flow from the catheter into the body of the device is restricted.
External blood flow from the device is further restricted by the sealing action between the boot and the internal wall of the catheter head. With the needle safely contained within the body of the device, the clinician applies digital pressure at the entry point of the catheter into the patient""s body to block blood flow from the catheter, removes the body of the device (which acts as a plug in the catheter head), and inserts the I-V line into the catheter head. Digital pressure is then removed, completing the process. An alternative embodiment of this invention provides for sequential depression of the individual release tabs to actuate needle retraction.
An alternative embodiment of this invention provides a second method of automatically plugging the nose of the device for flow restriction and added needle security.